RCS - Avingtrans PLC - Adaptix secures 510(k) clearance from FDA

AvingtransAnnouncement

30/01/2023 07:00

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RNS Number : 1744O  Avingtrans PLC  30 January 2023

30 January 2023

Avingtrans Plc

 

("Avingtrans" or the "Group")

 

Adaptix secures 510(k) clearance from FDA

 

Avingtrans PLC (AIM: AVG), which designs, manufactures and supplies critical
components, modules, systems and associated services to the energy, medical
and industrial sectors, announces that medical imaging technology associate
company Adaptix Limited (Adaptix) has received 510(k) clearance from the U.S.
Food and Drug Administration for its first orthopaedic medical imaging
product.

 

In 2021, Avingtrans invested £4m in Adaptix, for an 11.9% stake in the
business and in December 2022 announced a further investment of £2m by means
of a Convertible Loan.

 

The Board of Adaptix has made the following announcement:

 

Adaptix, based at Oxford University Science Park, has received 510(k)
clearance for its first medical imaging product. The first Adaptix medical
product is a Digital Tomosynthesis Orthopaedic imaging system. It is a
portable, low-dose imaging system capable of delivering fast, lower-cost,
X-ray imaging at the point of patient care. Developed specifically to offer 3D
X-ray imaging of hands, elbows and feet at a fraction of the radiation dose
and per-study price of traditional CT systems, the system provides clinicians
with clearer images than 2D X-ray systems, offering advantages in terms of
fewer acquisitions, accelerated patient workflow and enhanced diagnostic
accuracy.

 

Adaptix is already serving veterinary and industrial (Non-Destructive
Evaluation) markets using its novel and patent-protected technologies.
Receiving the 510(k) clearance is important as it is the first step in Adaptix
delivering its mission to transform radiology through provision of innovative
truly-portable 3D imaging technologies into healthcare providers.

 

Mark Evans, CEO of Adaptix, commented:

 

"We are delighted to receive the 510(k) clearance which allows this innovative
technology, and our first medical product, to be marketed in the world's
largest healthcare market. The team are energized by achieving this milestone,
and we look forward to delivering enhanced orthopaedic DT imaging systems; a
dental DT imaging system; and a chest DT imaging system for Intensive Care and
Emergency Department use. We see a future where 3D travels to the patient at
the point-of-care throughout hospitals, clinics and primary care transforming
patient pathways, improving patient experience, and reducing the cost of care
delivery."

 

Enquiries:

 

 Avingtrans plc                                          01354 692391

 Roger McDowell, Chairman

 Steve McQuillan, Chief Executive Officer

 Stephen King, Chief Financial Officer

 Singer Capital Markets (Nominated Adviser and Broker)   02074 963000

 Shaun Dobson

 Alex Bond

 Oliver Platts

 IFC Advisory (Financial PR)                             020 3934 6630

 Graham Herring

 Tim Metcalfe

 Zach Cohen

About Avingtrans plc:

 

Avingtrans designs, manufactures and supplies original equipment, systems and
associated aftermarket services to the energy, medical and industrial markets
worldwide.

 

Business units

 

 Hayward Tyler - Luton & East Kilbride, UK and USA, China and India

 Specialises in the design, manufacture and servicing of performance-critical
 motors and pumps for challenging environments.

 Energy Steel, Inc - Rochester Hills, Michigan, USA

 Energy Steel, part of the Engineered Pumps and Motors Division of
 Avingtrans plc, has been serving the nuclear power industry since 1982 with
 capabilities in equipment fabrication, material supply, precision machining,
 engineering, and repair services. Through strategic OEM partnerships, it also
 provides solutions for obsolete nuclear components and support for the most
 complex projects.

 Stainless Metalcraft Ltd - Chatteris, UK and Chengdu, China

 Provider of safety-critical equipment for the energy, medical, science and
 research communities, worldwide, specialising in precision pressure and vacuum
 vessels and associated fabrications, sub-assemblies and systems.

 Booth Industries - Bolton, UK

 Designs, manufactures, installs and services doors and walls which can be
 tailored to be: blast &explosion proof; fireproof; acoustically shielded;
 high security/safety; or combinations of the above

 Ormandy Group, Bradford, UK

 Design, manufactures and servicing of off-site plant, heat exchangers and
 other HVAC (heating, ventilation and air conditioning) products

 Composite Products Ltd - Buckingham, UK

 Centre for composite technology, parts and assemblies, serving customers in
 industrial markets.

 Magnetica Ltd - Brisbane, Australia

 Magnetica Limited specialises in the development of next generation MRI
 technologies, including dedicated extremity MRI systems and MRI system
 components. Magnetica has successfully built and tested a compact, integrated
 3 Tesla orthopaedic MRI system, demonstrating clinical-quality imaging.
 Commercialisation of this system (and others) is on-going. Magnetica's
 structure now includes two other business units:

 Scientific Magnetics - Abingdon, UK

 Designs and manufactures superconducting magnet systems and associated
 cryogenics for a variety of markets including MRI and provides services for
 Nuclear Magnetic Resonance instruments.

 Tecmag Inc, Houston, USA

 Designs, manufactures and installs instrumentation, including consoles, system
 upgrades, and probes, mainly for Magnetic Resonance Imaging (MRI) and Nuclear
 Magnetic Resonance (NMR) systems.

 

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